# FDA WARNING_LETTER - DiaPharma Group Inc - March 08, 2011

Source: https://www.keypedia.com/records/warning_letter/diapharma-group-inc/dbbac8dd-9ec9-448c-9b6f-dac3bc22e964

> FDA WARNING_LETTER for DiaPharma Group Inc on March 08, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: DiaPharma Group Inc
- Inspection Date: 2011-03-08
- Product Type: Devices
- Office Name: Cincinnati District Office
- Summary: On March 1-8, 2011, an FDA inspection of DiaPharma Group, Inc. in West Chester, Ohio, identified significant violations of the Quality System (QS) regulation (21 C.F.R. Part 820) for their in-vitro diagnostic Factor X test kits. These devices were deemed adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Key violations include:
1.  **Corrective and Preventive Action (CAPA):** Inadequate procedures (SOP #820.100) failing to identify all data sources (e.g., complaints, returned product, incoming inspection reports) for non-conforming product analysis. Only management reviews and internal quality audits were listed, neither of which were consistently performed or analyzed for trends.
2.  **Design Verification:** Failure to confirm design output met input requirements (21 C.F.R. § 820.30(f)). Discrepancies were noted in precision and accuracy acceptance criteria, with documented outputs not meeting established ranges or correlation coefficients.
3.  **Design Validation:** Failure to conduct design validation to ensure conformity to user needs and intended uses (21 C.F.R. § 820.30(g)). Specifically, no documentation verified the product maintained its required 2-8°C temperature during shipment since its

## Related Officers

- [Teresa C. Thompson](https://www.keypedia.com/people/teresa-c-thompson/b41b98e5-2a7c-4f19-923b-058a197a8fd4)

Company: https://www.keypedia.com/companies/diapharma-group-inc/6a1cbcec-21a2-48f8-8433-0c980a634b18

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22